Bellin Health Generations - Development Drive

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and records and interview with testing personnel (Staff A), the laboratory has not maintained a record system for all (approximately ten of ten) Fern tests performed in the last year that included the identification of the specimen, the date and time of specimen receipt, the disposition of unacceptable specimens, and the records and date of specimen testing including the identity of the personnel who performed the Fern test. Findings include: 1. Review of laboratory procedures revealed a procedure, "Fern Test", that showed laboratory personnel perform the Fern test slide evaluation. Further review showed nursing staff enter the Fern test result through the 'Enter / Edit Results' navigator in the electronic medical record (EMR). 2. Review of laboratory testing logs showed no evidence of Fern test evaluation or results. 3. Interview with Staff A on July 8, 2024, at 11:30 AM revealed the laboratory performed approximately 10 Fern tests per year. Further interview revealed providers brought the prepared slide to the laboratory for evaluation by laboratory staff. The testing personnel provided the Fern test results to the provider. Staff A further confirmed testing personnel did not retain records of the testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on survey review of laboratory records and the ASPEN WEB Clinical Laboratory Improvement Amendments (CLIA) database and interview with the technical consultant, the laboratory did not ensure compliance with regulations at 493. 51, Notification Requirements for Laboratories Issued a Certificate of Compliance and did not notify Health and Human Services (HHS) or its designee within thirty days of any change in director. Findings include: 1. Review of the laboratory procedure binder showed the following: Staff A: Laboratory Director, Effective: 2022- Present Staff B: Laboratory Director, Effective: 2021-2022 (Interim) Staff C: Laboratory Director, Effective: 2017-2021 Further review showed Staff A delegated the technical consultant duties in February 2022 and Staff B delegated the technical consultant duties on January 4, 2022. 2. Review of the ASPEN WEB CLIA database showed Staff A as the current laboratory director effective February 17, 2022, and staff C as the previous laboratory director. Further review showed no notification that staff B had served as the laboratory director for this location. 3. Interview with the technical consultant on October 18, 2022, at 10:40 AM revealed staff C had resigned from the location in December 2021 and staff B took over as laboratory director from Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- December 2021 through February 17, 2022, and staff A became the laboratory director on February 17, 2022. Further interview confirmed, the laboratory did not ensure compliance with regulations at 493.51, Notification Requirements for Laboratories Issued a Certificate of Compliance and did not notify Health and Human Services (HHS) or its designee within thirty days of any change in director. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the technical consultant, the laboratory director did not attest to the routine integration of the PT samples into the patient workload using the laboratory's routine methods. Findings include: 1. Review of PT records showed the director or designee had not signed the attestation statement for the first urinalysis event in 2018. 2. Interview with the technical consultant, staff A, on October 8, 2018 at 10:30 AM confirmed the director or a designee had not signed the attestation statement for the first urinalysis event in 2018 and did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This is a repeat deficiency previously cited on August 19, 2014 and August 25, 2010. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --